Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT01728857
Description: Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
Frequency Threshold: 0
Time Frame: From date of first treatment up to Week 16
Study: NCT01728857
Study Brief: Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
The ZELTIQ System Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0. 0 None 0 19 5 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Common Cold/Respiratory Infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stool impaction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Firmness or discrete nodules within the treatment area NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Numbness, tingling, burning lasting longer than 8 weeks NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View